MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC; INSTRUMENT, STEREOTAXIC

Model Number 9733560

Device Problems Calibration Problem (2890); Human-Device Interface Problem (2949)

Patient Problem No Patient Involvement (2645)

Event Date 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as there was no patient involved in this event.The hardware evaluation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a manufacturer representative regarding a navigation device being used outside of procedure.It was reported that "the product was out of criteria (2.0)." pn: 9733449, lot/sn: (b)(4).There was no patient involved in the event.

• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8701376
• MDR Text Key: 151846459
• Report Number: 1723170-2019-03352
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733560
• Device Catalogue Number: 9733560
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2017
• Date Device Manufactured: 03/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1